"The first thing people want to know in a case of suspected exposure is whether the agent was in fact anthrax," says Franklin R. Cockerill, III, M.D., the Mayo Clinic microbiologist who led the development team. "Until now, local labs have been able to quickly determine the presence of a bacterium, but they can’t tell whether it is anthrax or not. The current process to identify the presence of anthrax may take several days. The events of the last several weeks require as rapid a response as possible."

Roche plans to give regional and local laboratories the ability to perform rapid DNA testing, eliminating the waiting period currently required at most laboratories to identify anthrax. Thus, a larger number of laboratories will now be able to provide a rapid "yes" or "no" answer.

"This rapid identification will enable doctors to begin more timely treatment of patients who have been exposed to anthrax, and it will more quickly alleviate undue anxiety for people who haven’t been exposed," says Dr. Cockerill.

The Mayo Clinic team led by Dr. Cockerill developed the test using Roche's LightCycler® instrument for polymerase chain reaction (PCR)-based assays. To make the test widely available, Roche significantly accelerated production of the reagents needed to run the assay.

"Making this test available in a very short time frame is our contribution to the fight against bioterrorism and is a direct outcome of the excellent cooperation between Roche and Mayo Clinic," says Martin Madaus, President and CEO of Roche Diagnostics Corporation. "Mayo researchers have several years of experience in developing these types of assays. The speed and broad distribution of the LightCycler® made it an ideal platform for developing the anthrax test. By combining our efforts, we were able to make this test available to qualified laboratories only a few weeks after beginning this initiative."

The test materials will be made available to about two dozen geographically dispersed LightCycler®-equipped laboratories. The timing of local availability will vary location to location, but some may be available Nov. 9. Mayo Clinic has been working with the federal government to make the test formula available to federal agencies that request it, and is lending its expertise to state and federal health officials in the wake of the reported cases of anthrax exposure. Roche is working with the FDA to determine requirements for expedited regulatory approval. Initially, tests will be offered to laboratories at no charge.

"People who suspect they have been exposed to anthrax should contact local law enforcement officials, who will assess the situation and take appropriate steps," says Dr. Cockerill. "These officials will investigate possible exposures and, with local laboratories, will determine whether this rapid testing is warranted. Those who are experiencing unusual, flu-like symptoms should contact their physician."

Mayo Clinic recommends that it is best to have specimens tested at the nearest regional location to realize the full advantage of the rapid return of results that the new test offers.

"The time involved in transporting samples to Mayo Clinic also would undermine the main goal of the test, which is rapid identification," says Dr. Cockerill. "That’s why we have helped Roche make the test available locally, to speed the preliminary diagnosis and improve patient care. We are pleased that after a few weeks of round-the-clock efforts, that goal has been achieved."

Note: If no author is given, the source is cited instead.

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